drugset / Trial / NCT06799169

Management of Acute Tinnitus With Migraine Medications

NCT06799169

Phase 4 Active not recruiting 100 enrolled University of California, Irvine
RandomizedParallel-groupTriple-blindTreatment

Summary

Tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence the prevalence and risk of tinnitus. Although the economic and emotional impact of tinnitus is large, there is currently no FDA-approved medication to treat this condition. However, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. In this project, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.

Timeline

Start
2025-06-01
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nortriptyline Small molecule 60 mg Oral
Comparator Paroxetine Small molecule 32 mg Oral
Comparator Topiramate Small molecule 80 mg Oral
Comparator Verapamil Other / unclassified 240 mg Oral

Indications